UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045175 |
|---|---|
| Receipt number | R000051597 |
| Scientific Title | A study exploring new biomarkers by measuring the rest-activity rhythms of patients with schizophrenia and mood disorders |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2025/03/11 14:15:03 |
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Basic information
Public title
A study exploring new biomarkers by measuring the rest-activity rhythms of patients with schizophrenia and mood disorders
Acronym
A study exploring new biomarkers by measuring the rest-activity rhythms of patients with schizophrenia and mood disorders
Scientific Title
A study exploring new biomarkers by measuring the rest-activity rhythms of patients with schizophrenia and mood disorders
Scientific Title:Acronym
A study exploring new biomarkers by measuring the rest-activity rhythms of patients with schizophrenia and mood disorders
Region
| Japan |
Condition
Condition
Schizophrenia and mood disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Extraction of rest-activity rhythm characteristics in schizophrenia and mood disorders
Basic objectives2
Others
Basic objectives -Others
Developing the diagnostic marker and elucidation of the pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical characteristics of rest-activity rhythm
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Patients with schizophrenia and mood disorders (bipolar 1 disorder, bipolar 2 disorder, major depressive disorder) who are visiting Fujita Health University Hospital
-Patients with schizophrenia and mood disorders who participated in previous studies regarding rest-activity rhythm using actigraphy (retrospective use of data)
Key exclusion criteria
-Patients with prominent suicidal ideation
-Patients with depression apparently due to personality disorder
-Patients judged to be inappropriate by researchers
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
tsuyoshi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
Fujita Health University, School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
TEL
0562-93-9250
Homepage URL
tsuyoshi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192, JAPAN
Tel
0562-93-2865
r-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://ieeexplore.ieee.org/document/10411607
Number of participants that the trial has enrolled
97
Results
Data from previous studies using actigraphy were retrospectively analyzed. Actigraph data for subjects with schizophrenia (19 subjects), bipolar disorder (15 subjects), major depressive disorder (13 subjects), and sex- and age-matched healthy subjects (50 subjects) were included. Experimental results have demonstrated that the end-to-end method is effective in detecting diseases.
Results date posted
| 2024 | Year | 09 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The collected data will be analyzed for higher- and finer-order fluctuations that characterize diurnal variation and circadian rhythms using the latest machine learning methods such as deep learning, transfer learning, and data expansion, and the possibility of characterizing pathological conditions will be examined and evaluated.
Management information
Registered date
| 2021 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051597
